The Recall Desk
ModerateFDA (Devices)·Z-1912-2017·Announced 2017-05-10

Smith & Nephew Recalls Radial Osteotome Blades Due to Stability Data

Smith & Nephew is recalling specific lots of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,004 units of Renovation Radial Osteotome Blades, Size 16, Reference 71369316. The recall is being conducted because the stability data does not support the product labeled with a 10-year shelf life.

The affected products were distributed nationwide and in numerous international locations, including Australia, Canada, China, France, Great Britain, India, Japan, Mexico, and others. The recall covers specific batch numbers listed in the agency's structured data.

Healthcare providers and consumers should stop using the affected products and contact Smith & Nephew for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,004

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Batch numbers: 431604
  • 431612
  • 431614
  • 448956
  • 477931
  • 484324
  • 485498
  • 488987
  • 495483
  • 450002910
  • 4500029102
  • 4500031658
  • 08CSY0044
  • 08ESY0009
  • 08ESY0010
  • 08ESY0011
  • 08JSY0034
  • 08LSY0010
  • 10CSY0008
  • 10ESY0014

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

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Same hazard · shelf life mislabeling

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